Clinical Trials for Melanoma

Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion Before Tumor-Infiltrating Lymphocyte Therapy With Lifileucel in Metastatic Melanoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with unresectable stage IIIc/IV melanoma after 1–3 prior therapies (must include anti–PD‑1; BRAF/MEK if BRAF V600+) receive one-time autologous TIL therapy (lifileucel, polyclonal tumor-reactive T cells) following a reduced-dose fludarabine/cyclophosphamide lymphodepletion and up to 6 doses of IL‑2. Excludes uveal melanoma and active/untreated CNS disease; requires a resectable lesion for TIL harvest and ECOG 0–1.

ClinicalTrials.gov ID: NCT06151847

A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN 144/LN-145/LN-145-S1) in Patients With Solid Tumors

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: This trial enrolls patients with unresectable or metastatic melanoma (including those previously treated with PD-1 inhibitors or BRAF-targeted therapies), advanced head and neck squamous cell carcinoma, or locally advanced/metastatic non-small cell lung cancer, providing treatment with autologous tumor-infiltrating lymphocyte (TIL) products—lifileucel (LN-144/LN-145) or next-generation PD-1-selected LN-145-S1—either as monotherapy or in combination with immune checkpoint inhibitors (ICIs). Eligibility requires at least one resectable lesion and ECOG 0-1, and excludes active autoimmune disease or untreated symptomatic brain metastases.

ClinicalTrials.gov ID: NCT03645928

Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Patients With Select Solid Tumors

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Enrolling adults with advanced solid tumors requiring an injectable lesion: first-line PD-1–eligible HNSCC (PD-L1 CPS ≥1%, no prior PD-(L)1), cutaneous melanoma with primary resistance or progression on prior PD-(L)1 (BRAF+ should have received/declined targeted therapy), and a closed-to-enrollment non–MSI-H CRC cohort; ECOG 0–1 required. Treatment is intratumoral VV1 (VSV engineered to express IFN-β and NIS; oncolytic/immune-stimulatory) combined with IV cemiplimab every 3 weeks until progression/toxicity.

ClinicalTrials.gov ID: NCT04291105

Phase 1b/2 Trial of Defactinib and Avutometinib, With or Without Encorafenib, for the Treatment of Patients With Brain Metastases From Cutaneous Melanoma

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: Adults with cutaneous melanoma and measurable brain metastases after immune checkpoint inhibitors, including BRAF V600E/K–mutant and non‑BRAF cohorts; requires at least one untreated 0.5–4 cm parenchymal lesion, ECOG 0–1, and known RAS/BRAF/NF1 status. Treatment is avutometinib (dual RAF/MEK “clamp”) plus defactinib (FAK/Pyk2 inhibitor), with an added encorafenib (BRAF inhibitor) dose‑finding and expansion for BRAF V600E/K disease.

ClinicalTrials.gov ID: NCT06194929

An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination With PD1 Blockade in Patients With Solid Tumors

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adults with advanced, injectable solid tumors (ECOG 0–1) receive intratumoral RP1—an engineered oncolytic HSV‑1 expressing GM‑CSF and GALV‑GP R-—as monotherapy (dose escalation) or combined with nivolumab, with Phase 2 expansion in melanoma (post–anti‑PD‑1; BRAF status required), MSI‑H/dMMR tumors, non‑melanoma skin cancers, and NSCLC after PD‑1/PD‑L1 failure. Key exclusions include prior oncolytic therapy, significant HSV history/antiviral use, uncontrolled brain metastases, ILD/pneumonitis, and major cardiovascular disease.

ClinicalTrials.gov ID: NCT03767348

A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: This trial evaluates MDNA11, an IL-2 Superkine targeting the IL-2 beta receptor to enhance anti-tumor immunity, administered alone or with pembrolizumab, in adult patients with locally advanced or metastatic solid tumors. Eligible patients must have an ECOG performance status of 0 or 1 and adequate organ function.

ClinicalTrials.gov ID: NCT05086692

A Phase 1/2 Study of OR502 Alone and in Combination With Other Anti-cancer Agents in Subjects With Advanced Malignancies

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: This trial involves adult patients with advanced solid tumors, including those with platinum-resistant ovarian cancer or cutaneous squamous cell carcinoma, assessing the safety and efficacy of OR502, a monoclonal antibody targeting LILRB2 on tumor-associated macrophages, alone and with cemiplimab, an anti-PD-1 antibody.

ClinicalTrials.gov ID: NCT06090266

An Open-Label Phase 1a/1b Dose-Escalation and Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of AB248 Alone or in Combination with Pembrolizumab in Adult Patients with Locally Advanced or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: This trial enrolls adults with incurable, locally advanced, or metastatic solid tumors (ECOG 0-1, measurable disease, no active CNS metastases), testing the investigational IL-2 pathway–targeting fusion protein etakafusp alfa (AB248) alone or with pembrolizumab. AB248 is designed to selectively activate CD8+ T cells to enhance anti-tumor immunity while minimizing toxicity.

ClinicalTrials.gov ID: NCT05653882

A Phase 1 Study of SGN-PDL1V in Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: This trial enrolls adults with metastatic or unresectable, PD-L1–expressing solid tumors (including NSCLC, HNSCC, esophageal SCC, TNBC, ovarian cancer, melanoma, and gastric cancer) who have failed or are ineligible for standard therapies. Patients receive either SGN-PDL1V, an antibody-drug conjugate targeting PD-L1 and delivering MMAE, or a combination of SGN-PDL1V plus pembrolizumab.

ClinicalTrials.gov ID: NCT05208762

A Phase 1/2a, Open-Label, Multicenter, Nonrandomized, Safety and Anti-tumor Activity Study of IMM-1-104, a Novel Oral Dual MEK1/2 Inhibitor in Participants With Advanced or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with advanced or metastatic solid tumors harboring RAS mutations or RAS/MAPK pathway activation—including pancreatic, melanoma, and NSCLC—are eligible for treatment with IMM-1-104, a novel oral dual MEK1/2 inhibitor targeting the MAPK pathway, as monotherapy or in combination with agents such as pembrolizumab, dabrafenib, or standard chemotherapies. Eligible patients must have measurable disease and good performance status; both treatment-naive and previously treated patients are included depending on tumor type.

ClinicalTrials.gov ID: NCT05585320